510(k) K832965 ยท KLS Enzyme Immunoassay, Theophylline
STRATUS THEOPHYLLINE ASSAY
| Applicant | American Dade, Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 30, 1983 |
| Received | Sep 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832965
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.